Method and system to determine erroneous measurement signals during a test measurement sequence

• US 9,459,232 B2
• Filed: 09/05/2013
• Issued: 10/04/2016
• Est. Priority Date: 09/05/2013
• Status: Active Grant

• Current Assignee: Cilag Gmbh International (Johnson & Johnson)
• Original Assignee: LifeScan Scotland Limited (Johnson & Johnson)
• Inventors: Malecha, Michael, Strachan, Alexander, Gadde, Yeswanth
• Primary Examiner(s): NOGUEROLA, ALEXANDER STEPHAN
• Application Number:
  US14/018,910
• Publication Number:
  US 20150060300A1
• Time in Patent Office: 1,125 Days
• US Class Current: 1/1
• CPC Class Codes: G01N 27/3274 Corrective measures, e.g. error detection, compensation for temperature or hematocrit, calibration coding of calibration information G01N33/48771
• CPC Class Codes: G01N 27/3275 Sensing specific biomolecules, e.g. nucleic acid strands, based on an electrode surface reaction

Abstract

Various embodiments that allow a more accurate electrochemical test strip measurement by identifying erroneous output signals during a glucose measurement thereby ensuring a much more accurate glucose test system.

Claims

1. A glucose measurement system comprising:

a biosensor having a plurality of electrodes including at least two electrodes with an enzyme disposed thereon; and

a meter including;

a microcontroller coupled to a power source, memory and the plurality of electrodes of the biosensor and in which the microcontroller is configured to;

drive a signal to the at least two electrodes when a fluid sample comprising glucose is deposited proximate the at least two electrodes to start a test measurement sequence for an electrochemical reaction of the glucose in the fluid sample with the enzyme;

measure an output signal from at least one electrode during the electrochemical reaction over a series of time instances to obtain a magnitude of the output signal for each time instance;

determine an output differential as a difference in the respective magnitudes of the output signal for two consecutive time instances, at least one of the two consecutive time instances being within a predetermined time window during the test measurement sequence;

if the output differential is greater than zero then

(1) increment a first index by one and

(2) set a second index value as equal to

the sum of a previous value of the second index and the output differential

and

if the first index is greater or equal to a first threshold and

the second index is greater than a second threshold

then annunciate an error

otherwise if one of the two consecutive time instances is outside of the predetermined time window then calculate a glucose value from the output signal and annunciate the glucose value.

2. The system of claim 1, in which the predetermined time window is from about 1 second after a start of a test sequence to about 8 seconds after the start of the test sequence.

3. The system of claim 1, in which the first threshold is about 5 and the second threshold is about 300 nanoamperes.

4. The system of claim 1, in which the predetermined time window is from about 2 seconds after a start of a test sequence to about 8 seconds after the start of the test sequence.

5. The system of claim 1, in which the first threshold is about 5 and the second threshold is about 150.

6. A method of determining a glucose value from a fluid sample with a biosensor having at least two electrodes and reagent disposed thereon and a glucose meter having a microcontroller configured to connect to the biosensor and to a memory and a power source, the method comprising the steps of:

initiating a start of a test measurement sequence upon deposition of a fluid sample proximate the at least two electrodes of the biosensor;

applying an input signal to the fluid sample to cause a transformation of glucose into an enzymatic by-product;

measuring output signal transient from the fluid sample including over a predetermined time window from the start of the test sequence, the measuring including sampling an output signal from at least one electrode during the electrochemical reaction over a series of time instances to obtain a magnitude of the output signal for each time instance;

determining an output differential as a difference in the respective magnitudes of the output signal for two consecutive time instances, at least one of the two consecutive time instances being within the predetermined time window during the test measurement sequence;

if the output differential is greater than zero then;

(1) incrementing a first index by one and

(2) setting a second index value as equal to the sum of a previous value of the second index and the output differential;

and

if the first index is greater or equal to a first threshold and a second index is greater than a second threshold then annunciating an error,

otherwise if one of the two consecutive time instances is greater than the predetermined time window then calculating a glucose value of the fluid sample and annunciating the glucose value.

7. The method of claim 6, in which the calculating of the glucose value comprises measuring a magnitude of the output signal proximate a predetermined time instance from the start of the test sequence and deriving the glucose value from a first calibration value and a second calibration value.

8. The method of claim 7, in which the deriving comprises utilizing an equation of the form

G=[I−

Intercept]/Slope

where

G comprises a glucose value;

I comprises a summation of the magnitude of the signals measured from each of the electrodes proximate a predetermined time instance;

Slope comprises a value obtained from calibration testing of a batch of test strip of which this particular strip comes from; and

Intercept comprises a value obtained from calibration testing of a batch of test strip of which this particular strip comes from.

9. The method of claim 6, in which the predetermined time window is from about 1 second after a start of a test sequence to about 8 seconds after the start of the test sequence.

10. The method of claim 6, in which the first threshold is about 5 and the second threshold comprises about 300 nanoamperes.

11. The method of claim 6, in which the predetermined time window is from about 2 seconds after a start of a test sequence to about 8 seconds after the start of the test sequence.

12. The method of claim 6, in which the first threshold is about 5 and the second threshold is about 150.